In the United States, the occurrence of diabetes is on the rise. Major complications of diabetes include diabetic ulcers and amputation of the lower extremities. Diabetic ulcers precede the vast majority of diabetic amputations. Diabetic ulcers are thought to proceed due to micro and macro vascular complications that result in hypoxia and compromise the natural wound healing processes of the tissues in the affected limbs. As a result, the natural wound healing processes are unable to repair damaged tissue in ulcerative diabetic patients. Diabetic ulcers are an example of chronic wounds and hypoxia induced wounds. Treatments for diabetic ulcers, chronic wounds, and hypoxia induced wounds are needed.
Currently available treatments for chronic wounds that are the result of hypoxia and/or compromised wound healing processes typically include the use of therapies that attempt to replace the extracellular matrix in the wound to provide scaffolding on which healing can occur. Currently therapies typically employ advanced moist wound therapy techniques, control of infection, bioengineered tissue or skin substitutes, growth factors, and negative pressure therapy. However, each of these therapies has drawbacks that limit their use.
Therapeutic processes for improving healing of chronic wounds, hypoxia induced wounds, and diabetic ulcers are needed.
Endogenous physiological (40-250 mV/mm) electric field is an important component of the body's wound healing response. Different types of low, physiological amplitude electromagnetic field have been shown to influence a wide variety of biological systems and have been used as a therapeutic tool for tissue repair, including bone healing, soft tissue repair and the healing of chronic wounds. However, the widespread acceptance of electric field (EF) therapies for wound healing has not been adopted, and it is understood that no FDA-approved device for wound healing exists yet.